EUCTR2007-005402-53-NL进行中（未招募）不适用
Primary G-CSF prophylaxis during the first two cycles only or throughout all chemotherapy cycles in breast cancer patients at risk of febrile neutropenia - 2-2-6 STUDY
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •-Breast cancer patients =18 years
- •-Indication for 3-weekly chemotherapy.
- •-Chemotherapy in adjuvant, neo-adjuvant, advanced setting with an increased risk of febrile neutropenia, i.e.:
- •?regimes with >20% risk of febrile neutropenia: e.g. TAC (docetaxel, adriamycin, cyclophosphamide) or AT (adriamycine, docetaxel), or
- •?regimes with 10-20% risk of febrile neutropenia (e.g. AC, doxorubicin and vinorelbine, or docetaxel monotherapy) in the presence of =1 patient risk factor (>65 yrs, extensive bone marrow involvement or prior extensive radiotherapy on bone tissue, prior chemotherapy, ECOG performance status of 2 or less, grade 2 or higher liver function abnormalities).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Active uncontrolled infection.
- •-Inadequate renal or hepatic function.
- •-Any evidence or history of hypersensitivity or other contraindications to G-CSF medication.
- •-Not recovered from acute toxicities of prior therapies.
- •-Absolute neutrophil count (ANC) <1.5 x 109/l, not caused by bone marrow involvement.
研究者
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